DOPAMINE JUNO dopamine hydrochloride 200 mg/5 mL concentrated injection ampoules

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

dopamine hydrochloride, Quantity: 200 mg

Disponible desde:

Juno Pharmaceuticals Pty Ltd

formulario farmacéutico:

Injection, concentrated

Composición:

Excipient Ingredients: sodium chloride; potassium metabisulfite; water for injections; hydrochloric acid; sodium hydroxide

Vía de administración:

Intravenous Infusion

Unidades en paquete:

5

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

For the correction of haemodynamic imbalance present in: Acute hypotension or shock associated with myocardial infarction, endotoxic septicaemia, trauma and renal failure. As an adjunct after open heart surgery, where there is persistent hypotension after correction of hypovolaemia. In chronic cardiac decompensation as in congestive failure.

Resumen del producto:

Visual Identification: Ampoules containing a clear colourless or pale yellow solution; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estado de Autorización:

Registered

Fecha de autorización:

2021-06-24

Información para el usuario

DOPAMINE JUNO
1
DOPAMINE JUNO
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING DOPAMINE JUNO?
DOPAMINE JUNO contains the active ingredient dopamine hydrochloride.
Dopamine may be used to increase low blood
pressure in people who have a severe infection, experienced a heart
attack, lost blood during an accident, kidney failure or
problems after surgery. Dopamine may be used to help the heart pump
better in some people with congestive heart failure.
For more information, see Section 1. Why am I using DOPAMINE JUNO? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DOPAMINE JUNO?
Do not use if you have ever had an allergic reaction to dopamine or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
DOPAMINE JUNO? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with dopamine and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE DOPAMINE JUNO?
•
Your doctor will decide the appropriate dose for you.
•
A doctor or nurse will usually prepare and administer the injection or
infusion.
•
Follow all instructions given to you by your doctor and pharmacist.
More instructions can be found in Section 4. How do I use DOPAMINE
JUNO? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DOPAMINE JUNO?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are
receiving dopamine.
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how dopamine affects you.
Dopamine may cause dizziness in some people.
DRINKING
ALCOHOL
•
Tell your doctor if you drink alcohol. Alcohol may

Ficha técnica

Australian Product Information
Version: 2.0
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION
DOPAMINE JUNO (DOPAMINE HYDROCHLORIDE)
CONCENTRATED INJECTION_ _
_ _
1 NAME OF THE MEDICINE
Dopamine hydrochloride
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dopamine JUNO is a sterile solution containing dopamine hydrochloride
200 milligrams/5 mL.
The pH of the solution is between 2.5 and 5. IT MUST BE DILUTED BEFORE
USE.
EXCIPIENT WITH KNOWN EFFECT
Potassium metabisulfite
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Concentrated injection for infusion.
Ampoules containing a clear colourless or pale yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the correction of haemodynamic imbalance present in:
Acute hypotension or shock associated with myocardial infarction,
endotoxic septicaemia,
trauma and renal failure.
As an adjunct after open heart surgery, where there is persistent
hypotension after correction
of hypovolaemia.
In chronic cardiac decompensation as in congestive failure.
4.2 DOSE AND METHOD OF ADMINISTRATION
In appropriate cases, restoration of blood volume with plasma, whole
blood, or a suitable
plasma expander, should be instituted prior to administration: central
venous pressure should
be 10 to 15cm H
2
O, or pulmonary wedge pressure 14 to 18mm Hg.
WARNING: DOPAMINE IS A POTENT DRUG. IT MUST BE DILUTED BEFORE
ADMINISTRATION.
DO NOT ADD TO ALKALINE SOLUTIONS SUCH AS SODIUM BICARBONATE, AS THESE
INACTIVATE
DOPAMINE.
Australian Product Information
Version: 2.0
Page 2 of 13
Product is for single use in one patient only. Discard any residue
DOSAGE
_ADULT _
When appropriate, increase blood volume with a suitable plasma
expander, whole blood or
plasma until central venous pressure is 10 to 15 cm H
2
O or pulmonary wedge pressure is 14
to 18 mm Hg. Begin administration of diluted solution at doses of 2 to
5 micrograms/kg/min
in patients who are likely to respond to modest increments of heart
force and renal perfusion
(see table under SECTION 5 PHARMACOL